Contribution of SuPAR for Patients in a Situation of Uncertainty Downstream of Emergencies (SuPAR)

March 10, 2023 updated by: University Hospital, Clermont-Ferrand
In this study, the investigators will investigate the relationship between the blood level of SuPAR at admission to the emergency department of the Clermont-Ferrand University Hospital, and the outcome of patients after their hospitalization in a short stay unit.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

SuPAR (Soluble urokinase Plasminogen Activator Receptor) is a non-specific prognostic blood biomarker related to inflammation. An elevated SuPAR value reflects significant chronic inflammation and predicts a risk of negative outcome and even short-term mortality (intra-hospital, 30 days, 90 days). Conversely, a low SuPAR value is a strong indicator of good prognosis and low risk of readmission. It is therefore of interest to know a patient's SuPAR blood level to enable the clinician to decide whether the patient should be admitted or discharged. SuPAR has been shown to be the best prognostic marker associated with the presence and progression of disease and risk of mortality. The use of SuPAR in clinical routine adds significant complementary information to the standard Early Warning Score assessment and to the classical parameters such as CRP, PCT, Lactate, ALT, Bilirubin, and CBC in the pre-admission of acute patients.

Patients admitted to the emergency department will receive their usual management. We will test the added value of the SuPAR assay in the prognosis of patients' outcome at discharge.

Study Type

Observational

Enrollment (Actual)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Clermont-Ferrand, France
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

all patients requiring clinical observation for a final referral decision and meeting the eligibility criteria will be offered the study

Description

Inclusion Criteria:

  • Patient, male or female, over 18 years old
  • Admitted to the emergency department of the Clermont-Ferrand University Hospital for a medical reason,
  • Classified as FRENCH II or III by the nurse organizer of the reception management
  • Necessity of clinical observation in the Short Term Hospitalization Unit for final orientation decision
  • Requires a blood test upon arrival in the emergency department
  • Able to give informed non-opposition to participate in the research.
  • Affiliation to a Social Security system

Exclusion Criteria:

  • Patient under guardianship or curatorship
  • Pregnant and breast feeding woman
  • Patient admitted for psychiatric pathology
  • Patient with a limitation of therapeutics
  • Refusal to participate
  • Patient hospitalized because of a particular social context

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental
Retrospective analysis of the correlation between SuPAR measurement and patient outcome after hospitalization
The supar values will be measured afterwards on the tube bottoms of the patients included in the study from their usual collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between blood supar levels and patient outcome at discharge
Time Frame: When the excepted 150 patients will be included, estimated 6 months
Relation between blood supar levels measured and patient outcome at discharge evaluated as : return home = good evolution; hospitalization = bad evolution; admission to an intensive care unit or death = unfavorable evolution
When the excepted 150 patients will be included, estimated 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Early Warning Score 2 (NEWS2)
Time Frame: Hour 0
Score allowing the classification of the urgency of a patient. The minimum value is 0 and the maximum value is 20. Higher scores mean a worse outcome
Hour 0
Modified Early Warning Score (MEWS)
Time Frame: Hour 0
Score allowing the classification of the urgency of a patient. The minimum value is 0 and the maximum value is 17. Higher scores mean a worse outcome
Hour 0
Blood supar levels
Time Frame: When the excepted 150 patients will be included, estimated 6 months
the supar values are classifies into three categories : < 3 ng/ml : supports the referral decision. the patient's general condition is good and the prognosis is high 3-6 ng/ml : presence of pathologies and comorbidity factors. readmissions and high mortality beyond 6 months >6 ng/ml : requires special clinical attention, high risk of mortality
When the excepted 150 patients will be included, estimated 6 months
Blood CRP value
Time Frame: Hour 0
the CRP value will be assessed during the blood test performed as part of the classical management when the patient arrives in the emergency room
Hour 0
Cardiac frequency
Time Frame: Hour 0
cardiac frequency will be evaluated when the patient arrives in the emergency service as part of the classical management
Hour 0
Respiratory rate
Time Frame: Hour 0
respiratory rate will be evaluated when the patient arrives in the emergency service as part of the classical management
Hour 0
Temperature
Time Frame: Hour 0
the temperature will be evaluated when the patient arrives in the emergency service as part of the classical management
Hour 0
Systolic blood pressure
Time Frame: Hour 0
systolic blood pressure will be evaluated when the patient arrives in the emergency service as part of the classical management
Hour 0
Diastolic blood pressure
Time Frame: Hour 0
diastolic blood pressure will be evaluated when the patient arrives in the emergency service as part of the classical management
Hour 0
French triage
Time Frame: Hour 0
French Emergency Nurses Classification in Hospitals (FRENCH) ranks priorities from 5 to 1 (from least urgent to most urgent) according to prognosis and complexity/severity of the medical condition
Hour 0
Main diagnosis retained by the physician
Time Frame: at the end of hospitalization
Main diagnosis retained
at the end of hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fares MOUSTAFA, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2022

Primary Completion (Actual)

April 18, 2022

Study Completion (Actual)

April 18, 2022

Study Registration Dates

First Submitted

December 8, 2021

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI 2021 MOUSTAFA
  • 2021-A01930-41 (Other Identifier: 2021-A01930-41)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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